|Publication number||US9713549 B2|
|Application number||US 11/047,319|
|Publication date||25 Jul 2017|
|Filing date||31 Jan 2005|
|Priority date||2 Feb 2004|
|Also published as||CA2555009A1, CA2555009C, EP1711143A1, EP1711143B1, US20050192616, WO2005074844A1|
|Publication number||047319, 11047319, US 9713549 B2, US 9713549B2, US-B2-9713549, US9713549 B2, US9713549B2|
|Inventors||Jeffrey P. Callister, William S. Tremulis|
|Original Assignee||Bayer Healthcare Llc|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (121), Non-Patent Citations (57), Classifications (18), Legal Events (6)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims priority to U.S. Provisional Application No. 60/541,821 filed Feb. 2, 2004, which is incorporated herein by reference in its entirety.
This invention generally relates to the field of occluding devices, delivery systems for such devices and the method of using such devices and systems in the occlusion of body passageways. The invention is particularly useful for the occluding reproductive lumens such as a female patient's fallopian tubes or a male patient's vas deferens to affect contraception.
Conventional contraceptive strategies generally fall within three categories: physical barriers, drugs and surgery. While each have certain advantages, they also suffer from various drawbacks. Barriers such as condoms and diaphragms are subject to failure due to breakage, displacement and misplacement. Drug strategies, such as the pill and Norplant™, which rely on artificially controlling hormone levels, suffer from known and unknown side-effects from prolonged use. Surgical procedures, such as tubal ligation and vasectomy, are very effective, but involve the costs and attendant risks of surgery, and are frequently not reversible.
Recently, minimally invasive treatments have be proposed which deploy occluding stent-like devices within reproductive lumens, e.g. the fallopian tubes or vas deferens, as a contraceptive alternative to tubal ligation or vasectomy. However, placing a stent or similar occluding device may not create sufficient or permanent obstruction of the reproductive lumen depending on the nature of the obstructive device. For example, the obstructive device may be too small to provide complete obstruction of the reproductive lumen, or the device may be permeable to cell movement. An occluding device placed in a reproductive lumen, for example, may not securely seal against the luminal walls, or may initially allow egg cells or sperm cells to pass through the device until tissue growth completes the occlusion of the reproductive lumen and thus allow pregnancy to occur. Additionally, the occluding device might create an initial obstruction sufficient to prevent the passage of an egg but allow sperm cells to pass through or by the occluding device, fertilizing an egg upstream of the obstruction and resulting in an ectopic pregnancy.
The use of an occluding contraceptive or sterilization device, particularly with mesh or fibrous material to promote tissue ingrowth, has been proposed (See for example U.S. Pat. Nos. 6,096,052 and 6,432,116). However, with these devices there is an initial period (several weeks to several months) after deployment during which the patient is at risk for cell passage through the device that can result in pregnancy. In such situations it may be desirable to use a supplemental method of birth control until tissue ingrowth effectively occludes the fallopian tube. The same initial risks are found when occluding a male's vas deferens.
Even in situations in which complete obstruction has been achieved initially, the body lumen may recannalize. For example, an obstruction placed in a fallopian tube may create an initial blockage that obstructs passage of sperm or eggs. However, over time the walls of the tube may reconfigure to create a channel around the obstruction, effectively recannalizing the fallopian tube.
The present invention relates devices and methods for occluding a body lumen, particularly a reproductive body lumen such as a female patient's fallopian tube or a male patient's vas deferens, which effectively occludes the body lumen initially and over the long term.
Occluding devices which incorporate features of the invention generally have an expandable occluding component configured for deployment within the patient's body lumen such as a reproductive lumen. The occluding component has an impermeable barrier element secured thereto which is substantially impermeable to the passage of biological components such as cells, particularly reproductive cells such as eggs and sperm cells to provide an immediate barrier, i.e. at the time of deployment. The occluding component also has one or more permeable components that are secured to, disposed within or otherwise part of the occluding component to facilitate tissue growth that provides long term or permanent occlusion. Tissue growth can be into or onto the occluding component to at least partially occlude the reproductive lumen. Tissue growth may include epithelialization, scar formation, cell proliferation, or other cell growth or multiplication.
One occluding device embodying features of the invention has an occluding component in the form of a stent-like structure which has an impermeable barrier component to ensure initial occlusion of the body lumen and a permeable component to facilitate tissue ingrowth into or onto the stent-like structure of the occluding component for long term or permanent occlusion thereof.
In one embodiment, the impermeable barrier component is an inflatable and detachable balloon formed of impermeable material. The stent-like structure is mounted onto an impermeable, inflatable and detachable balloon of a delivery device such as a catheter. and the distal end of the delivery device is introduced into the body lumen and advanced therein until the detachable balloon is disposed in the location where the user desires to place the occluding device. The balloon is then inflated to the desired size, preferably to the diameter or a slightly larger dimension than the diameter of the body lumen. The expansion of the balloon expands the stent-like structure mounted on the balloon and against the wall of body lumen. After inflation, the shaft of the delivery catheter is disengaged from the detachable balloon portion of the delivery catheter and then withdrawn, leaving the stent-like structure in place against the walls of the body structure with the inflated, detached balloon disposed within the inner lumen of the stent-like occluding component. One or more permeable components such as fibrous mesh, a fiber bundle or a porous polymeric mass or plug are provided within the occluding component to facilitate tissue ingrowth and over time to create an effective and permanent occlusion of the body lumen.
A modification of the embodiment described above is to provide an impermeable diaphragm or membrane within the inner lumen of the stent-like occluding component or over one or more ends of the stent-like occluding component that seals the lumen of the stent when the stent-like structure is expanded against the walls of the body structure. The stent-like occluding component may be balloon expandable or self-expandable. A fibrous or otherwise porous mass or body, for example strands or bundles of biocompatible fibers or open cell biocompatible foam, may be provided within the stent-like structure as described above to facilitate tissue ingrowth.
A self-expanding occluding component may be formed of a superelastic metal such as NiTi which has been treated to have a stable austenite phase at body temperature and stress induced or stress maintained martensite phase. The occluding component may be in one, small diameter configuration for delivery in a suitable delivery catheter and expand upon discharge from the delivery catheter to a larger dimensioned second configuration within the body lumen. Alternatively, the occluding component may be formed of shape memory metallic material such as NiTi alloy which has a stable martensite phase at body temperature but which expands to a remembered larger diameter configuration when heated to transform the martensite to the austenite phase.
An expandable mass such as a plug on the interior of the occluding component may also to provide the expansion or augment natural or other expansion of the occluding component. The expandable mass may be the impermeable barrier component or the permeable component which facilitates tissue ingrowth.
Another occluding device embodying features of the invention is an occluding component comprising an expandable plug having a plurality of segments, at least one of which is an impermeable barrier component for initial occlusion of the body lumen and at least one of which is a permeable component configured to facilitate tissue ingrowth that provides a long term or permanent occlusion. The plug is configured to be compressible for delivery within a delivery sheath and to be expandable within the body lumen when discharged from the delivery sheath. The impermeable barrier segment may be an impermeable membrane or a closed cell mass or both. The permeable segment may be a fibrous or porous mass or both. The occluding component of this embodiment may have a stent-like attachment ring at one or both ends of the occluding device to secure the occluding component at least partially within the body lumen. The occluding component or attachment rings may be provided with anchoring elements such as hooks or barbs to secure the occluding component within the body lumen. The expanded occluding device provides an immediately effective occlusion of the body lumen, while tissue ingrowth over time provides a permanent and effective occlusion of the body lumen.
The occluding component may have the structure described in copending application Ser. No. 10/746,131, filed on Dec. 24, 2004, assigned to the present assignee which discloses an occluding component having one or more expanding spider-like elements. The impermeable barrier component is an impermeable membrane secured to the expanding legs of the spider-like element to provide initial occlusion of the body lumen. Fibrous or porous material may be secured to the expanding legs of the spider-like elements or to a central support shaft or spine connecting spider-like elements of the occluding component.
Other occluding components embodying features of the invention may comprise a plurality of expandable disks on a shaft in which at least one of the disks is an impermeable barrier component and at least one is a permeable component as described above.
Another occluding device has a stent-like occluding component with an enlarged bullet shaped impermeable barrier component on the leading end of the occluding component. One or more permeable components may be disposed in the interior of the occluding component.
The occluding component will generally be about 1 to about 5 mm, preferably about 2 to about 4 mm in transverse dimension in the expanded configuration and will generally be about 0.5 to about 8 cm, preferably about 1.5 to about 4 cm in length. While the description herein is focused on the use of only one occluding device, two or more occluding devices may be employed in a reproductive lumen.
The occluding devices and methods of using such occluding devices embodying features of the invention are effective both initially and over the long term in occluding the body lumen sufficiently to prevent the passage therethrough of undesirable biological elements, e.g. cells. The methods and devices are particularly beneficial for occluding reproductive lumens for contraceptive purposes. Although the occlusion of a patient's reproductive lumens are discussed herein in detail, it can be appreciated that the devices, methods and systems described herein can easily be adapted to occlude a patient's arteries or veins in a variety of situations, the nidus of an arterial-venous malformation, patent ductus arteriosis in infants, as well as arteries feeding blood to cancerous tumors.
These and other features of this invention will become more apparent in light of the detailed description of the invention and the exemplary drawings contained herein.
The balloon-like barrier component 12 is formed of impermeable, biocompatible polymeric material. Suitable polymeric materials include polyethylene terephthalate (PET), nylon and polyesters such as Hytrel®. Other moderately-compliant to essentially non-compliant biocompatible polymeric materials are suitable. Biocompatible and bioresorbable materials such as polylactic acid, polyglycolic acid, polycaprolactone and blends and copolymers thereof are also suitable in some instances.
A plurality of fibrous permeable components 20 and 21 are provided within the stent-like occluding component 11 at each end thereof to facilitate tissue ingrowth therein. The permeable components may be a mass of fibrous material as shown, or a plug or mass of porous polymeric material.
The occluding member 10 is advanced to the desired location within the body lumen 22, such as a female patient's fallopian tube, with the stent-like occluding component 11 mounted on the balloon-like barrier element 12 in a non-inflated condition. Inflation fluid (indicated by the arrows 23 in
The balloon of the occluding component 11 will be inflated with sufficient pressure to press the stent like component 11 against the wall of the body lumen 22 and form a secure seal between the balloon and the body lumen wall, but not with sufficient force to rupture or otherwise damage the lumen or the balloon. The detachable distal shaft section 14 of the delivery catheter 15 is detached from the balloon assembly by rotating the shaft to unscrew the shaft section from the balloon section. After detaching the shaft 15 from the balloon, the back-flow valve 18 prevents fluid in the body lumen from traveling back up the inner lumen 19 of the delivery catheter 15. The one-way valve 16 adjacent the balloon prevents loss of inflation fluid and ensures that the balloon remains in the inflated condition.
The balloon of the impermeable barrier component 12 is made of a material which is impermeable to preselected biological elements in order to seal the body lumen and prevent the passage of such biological elements. As used herein, “impermeable” means impermeable to the extent and appropriate for the purpose. For example, a barrier for contraceptive purposes in a reproductive lumen such as a fallopian tube or vas deferens is impermeable if, when placed across the reproductive lumen, it will block the passage of sperm cells or an egg through the reproductive lumen. The barrier need not be air tight, fluid tight (indeed the ability to pass some fluid might be desirable) and may even allow the passage and ingrowth of smaller cells. It need only be sufficiently impermeable in this use to seal the reproductive lumen sufficiently to effect contraception.
The stent-like occluding component 11 will usually have an open walled structure and will be permeable enough to allow tissue growth into the interior thereof. The stent-like occluding component 11 has at least one end portion that extends beyond the ends of the balloon-like barrier component 12. The proximal end portion 25 or the distal end portion 26 or both of the stent-like occluding component 11 which extend beyond the barrier component 12 have fibrous members 20 and 21 within them to facilitate and support tissue ingrowth for long term or permanent occlusion of the body lumen. Hooks or barbs 27 are provided on the stent-like occluding component 11 to secure the occluding device within the body lumen 22 when in the expanded configuration as shown in
The occluding device 50 is releasably attached to the distal shaft section of delivery catheter (not shown) in a similar manner to that shown in
In use, the compressible occluding device 50 will be compressed to fit within the inner lumen of a delivery sheath (not shown). The occluding device 50 may be constrained within a stent-like tubular structure (not illustrated) or may be a free-standing device. When the occluding device 50 has been advanced to the desired place in the patient's body lumen, e.g. a fallopian tube and discharged the intermediate foam segment 54 usually expands because there is no further constraints and the segment is biased to expand. Inflation fluid is injected into the interior of the inflatable segments 52 and 53 of the occluding component 51 through the inner lumen of tubular member 57. Likewise, the inflatable end segments 53 and 54 of the occluding component 51 will generally be inflated to essentially the same diameter or a slightly larger diameter of the body lumen so that the exterior surface of the occluding component segments 52 and 53 are snugly pressed against the lumen wall defining the body lumen. The expansion of the intermediate, foam segment 54 may be assisted by the inflation of the end segments 52 and 53, if these inflatable end segments are attached to the ends of the intermediate foam segment 54.
Once the inflatable end segments are inflated within a body lumen (not shown), the distal shaft section 55 of the delivery catheter 56 is detached from the occluding device 50 by rotating the distal shaft section 55 counter clockwise to undo the threaded connection 59 therebetween and then withdrawn the delivery catheter 56. The one way valve 55 prevents inflation fluid within the end segments 52 and 53 from escaping and helps maintain the inflated end segments in their inflated configuration. Because the impermeable end segments 52 and 53 are pressed snugly against the body lumen wall, an effective occlusion of the body lumen occurs that is immediately effective and continues to be an effective barrier until tissue growth into and onto the occluding component 51 effectively occludes and seals the body lumen. By the time the tissue of the body lumen is capable of regrowing and reorganizing to form a bypass around the obstruction (i.e. recannalize), tissue ingrowth into the foam section has formed a permanent occlusion and the body lumen has been effectively and permanently sealed.
For example, if this device were placed in a fallopian tube, the balloon segments would form an immediate occlusion to prevent the passage of egg cells down the fallopian tube or sperm cells up the fallopian tube, effectively providing immediate contraception by the impermeable balloon in the fallopian tube. By the time the fallopian tube could form a new channel around the balloon structures, a process that might take several weeks to several months, tissue ingrowth into the open celled foam of the permeable component 54 between the impermeable segments 52 and 53 would permanently seal the fallopian tube, thus providing permanent contraception.
Essentially the entire occluding component 71 is compressible to facilitate delivery within a delivery sheath (not shown, but see
The segments 72 and 73 may be separated by an impermeable membrane 74, or may be merely formed in alternating sections. At least one segment will generally be permeable to support cell ingrowth, and at least one segment will generally be impermeable to form an immediately effective barrier to cellular migration through the body lumen, although only the membrane may be impermeable and may form the impermeable barrier.
A further alternative embodiment is depicted in
An additional alternative occluding device 110 having features of the invention is depicted in
While not shown in
Impermeable disk 112 effects an immediate barrier to the passage of undesirable biological components such as eggs and sperm cells and permeable disks 113 and 114 facilitate tissue ingrowth for permanent occlusion. The disks forming the occluding device 110 should have sufficient length to diameter aspect ratios to create a slightly cylindrical shape to enhance the placement and ensure that the disks do not rotate into a flat position that would not effectively seal the body lumen.
Another embodiment of an effective occluding device 150 having features of the present invention is shown in
The stent-like members described herein can be formed of conventional stent materials including stainless steel, NiTi alloy (shape memory and superelastic), MP35n, Elgiloly and the like. The impermeable materials may be formed of somewhat compliant to essentially non-compliant biocompatible polymeric materials such as PET, nylon Hytrel® and the like. The permeable materials can be fibrous materials such as polyester, nylon, and the like or porous polymeric foam materials impermeable closed cell foam and permeable open cell foam may be formed of expanded polytetraflouroethyene (ePTFE).
Various modifications and improvements may be made to the present invention without departing from the scope thereof. For example, while the invention has been discussed primarily in terms of occluding a reproductive body lumen, the occluding device may be used to occlude a variety of body lumens or passageways. Moreover, although individual features of the invention may be described with respect to one or more of the embodiments but not in other embodiments, those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of one or more of other embodiments.
Terms such as “element”, “member”, “device”, “section”, “portion”, “component”, “means”, “step” and words of similar import, when used in the following claims, shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the claims expressly use the term “means” followed by a particular function without specific structure or the term “step” or “steps” followed by a particular function without specific action. The full disclosures of all patents and patent applications referred to are incorporated herein by reference.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3334629||9 Nov 1964||8 Aug 1967||Bertram D Cohn||Occlusive device for inferior vena cava|
|US3687129||2 Oct 1970||29 Aug 1972||Abcor Inc||Contraceptive device and method of employing same|
|US3815578||11 May 1973||11 Jun 1974||Investors In Ventures Inc||Method of inserting an implant into a portion of a tubular organ whose mucous lining has been partially removed|
|US3834394||23 Feb 1972||10 Sep 1974||J Hunter||Occlusion device and method and apparatus for inserting the same|
|US3855996||1 Mar 1973||24 Dec 1974||Medtronic Inc||Contraceptive apparatus and procedure|
|US3865108||9 Jul 1973||11 Feb 1975||Ortho Pharma Corp||Expandable drug delivery device|
|US3868956||5 Jun 1972||4 Mar 1975||Ralph J Alfidi||Vessel implantable appliance and method of implanting it|
|US3991760||2 Dec 1975||16 Nov 1976||The Procter & Gamble Company||Vaginal medicament dispensing means|
|US4052754||14 Jul 1976||11 Oct 1977||Homsy Charles A||Implantable structure|
|US4140126||18 Feb 1977||20 Feb 1979||Choudhury M Hasan||Method for performing aneurysm repair|
|US4185618||26 Jun 1978||29 Jan 1980||Population Research, Inc.||Promotion of fibrous tissue growth in fallopian tubes for female sterilization|
|US4246896||30 Oct 1978||27 Jan 1981||Dynatech Corp.||Intracervical cuff (ICC) for contraception and prevention of venereal disease and applicator therefor|
|US4279252||24 Aug 1979||21 Jul 1981||Martin Michael T||X-ray scaling catheter|
|US4311146||8 May 1980||19 Jan 1982||Sorenson Research Co., Inc.||Detachable balloon catheter apparatus and method|
|US4441495||16 Aug 1982||10 Apr 1984||Becton, Dickinson And Company||Detachable balloon catheter device and method of use|
|US4503569||3 Mar 1983||12 Mar 1985||Dotter Charles T||Transluminally placed expandable graft prosthesis|
|US4562596||25 Apr 1984||7 Jan 1986||Elliot Kornberg||Aortic graft, device and method for performing an intraluminal abdominal aortic aneurysm repair|
|US4579110||18 Nov 1983||1 Apr 1986||Jacques Hamou||Tubular pessary as a contraceptive means|
|US4595000||21 May 1984||17 Jun 1986||Jacques Hamou||Tubular pessary as a contraceptive means|
|US4606336||23 Nov 1984||19 Aug 1986||Zeluff James W||Method and apparatus for non-surgically sterilizing female reproductive organs|
|US4638803||30 Nov 1984||27 Jan 1987||Rand Robert W||Medical apparatus for inducing scar tissue formation in a body|
|US4657000||8 Aug 1984||14 Apr 1987||Dynasplints Systems, Inc.||Adjustable splint and securing means therefor|
|US4688553||14 Nov 1985||25 Aug 1987||L. G. Medical S.A.||Filter, particularly for trapping blood clots|
|US4700701||23 Oct 1985||20 Oct 1987||Montaldi David H||Sterilization method and apparatus|
|US4705517 *||3 Sep 1985||10 Nov 1987||Becton, Dickinson And Company||Percutaneously deliverable intravascular occlusion prosthesis|
|US4733665||7 Nov 1985||29 Mar 1988||Expandable Grafts Partnership||Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft|
|US4787899||10 Dec 1986||29 Nov 1988||Lazarus Harrison M||Intraluminal graft device, system and method|
|US4869268||13 Oct 1988||26 Sep 1989||Inbae Yoon||Multi-functional instruments and stretchable ligating and occluding devices|
|US4964850||2 Jun 1989||23 Oct 1990||Vincent Bouton||Method for treating trans-nasal sinus afflictions using a double t-shaped trans-nasal aerator|
|US4969458||6 Jul 1987||13 Nov 1990||Medtronic, Inc.||Intracoronary stent and method of simultaneous angioplasty and stent implant|
|US4994069||2 Nov 1988||19 Feb 1991||Target Therapeutics||Vaso-occlusion coil and method|
|US5104399||9 Mar 1988||14 Apr 1992||Endovascular Technologies, Inc.||Artificial graft and implantation method|
|US5108420||1 Feb 1991||28 Apr 1992||Temple University||Aperture occlusion device|
|US5147370||12 Jun 1991||15 Sep 1992||Mcnamara Thomas O||Nitinol stent for hollow body conduits|
|US5163958||13 Aug 1991||17 Nov 1992||Cordis Corporation||Carbon coated tubular endoprosthesis|
|US5167614||29 Oct 1991||1 Dec 1992||Medical Engineering Corporation||Prostatic stent|
|US5176692||9 Dec 1991||5 Jan 1993||Wilk Peter J||Method and surgical instrument for repairing hernia|
|US5190546||9 Apr 1991||2 Mar 1993||Raychem Corporation||Medical devices incorporating SIM alloy elements|
|US5192301||3 Sep 1991||9 Mar 1993||Nippon Zeon Co., Ltd.||Closing plug of a defect for medical use and a closing plug device utilizing it|
|US5197978||26 Apr 1991||30 Mar 1993||Advanced Coronary Technology, Inc.||Removable heat-recoverable tissue supporting device|
|US5226911||2 Oct 1991||13 Jul 1993||Target Therapeutics||Vasoocclusion coil with attached fibrous element(s)|
|US5267945||24 Apr 1991||7 Dec 1993||David Doctor||Finger splint for treating pip joint injuries|
|US5275622||13 Jul 1990||4 Jan 1994||Harrison Medical Technologies, Inc.||Endovascular grafting apparatus, system and method and devices for use therewith|
|US5303719||25 Jun 1993||19 Apr 1994||Wilk Peter J||Surgical method and associated instrument assembly|
|US5354295||24 Feb 1992||11 Oct 1994||Target Therapeutics, Inc.||In an endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas|
|US5366472||30 Sep 1991||22 Nov 1994||Cordis Corporation||Dilatation balloon within an elastic sleeve|
|US5370657||26 Mar 1993||6 Dec 1994||Scimed Life Systems, Inc.||Recoverable thrombosis filter|
|US5382259||26 Oct 1992||17 Jan 1995||Target Therapeutics, Inc.||Vasoocclusion coil with attached tubular woven or braided fibrous covering|
|US5382261||1 Sep 1992||17 Jan 1995||Expandable Grafts Partnership||Method and apparatus for occluding vessels|
|US5423849||15 Jan 1993||13 Jun 1995||Target Therapeutics, Inc.||Vasoocclusion device containing radiopaque fibers|
|US5433217||29 Nov 1993||18 Jul 1995||Pianetti; Francesco||Bimetallic spiral intrauterine device|
|US5443500||8 Apr 1994||22 Aug 1995||Advanced Cardiovascular Systems, Inc.||Intravascular stent|
|US5456713||30 Nov 1993||10 Oct 1995||Cook Incorporated||Expandable transluminal graft prosthesis for repairs of aneurysm and method for implanting|
|US5474089||26 Jun 1991||12 Dec 1995||The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services||Method and device for reversible sterilization|
|US5489295||21 May 1993||6 Feb 1996||Endovascular Technologies, Inc.||Endovascular graft having bifurcation and apparatus and method for deploying the same|
|US5499995 *||25 May 1994||19 Mar 1996||Teirstein; Paul S.||Body passageway closure apparatus and method of use|
|US5507811||15 Nov 1994||16 Apr 1996||Nissho Corporation||Prosthetic device for atrial septal defect repair|
|US5512051||21 Jun 1995||30 Apr 1996||Boston Scientific Corporation||Slip-layered catheter balloon|
|US5514176||20 Jan 1995||7 May 1996||Vance Products Inc.||Pull apart coil stent|
|US5545210||22 Sep 1994||13 Aug 1996||Advanced Coronary Technology, Inc.||Method of implanting a permanent shape memory alloy stent|
|US5601593||18 Aug 1995||11 Feb 1997||Willy Rusch Ag||Stent for placement in a body tube|
|US5601600||8 Sep 1995||11 Feb 1997||Conceptus, Inc.||Endoluminal coil delivery system having a mechanical release mechanism|
|US5643311||22 Sep 1995||1 Jul 1997||Clinical Innovation Associates, Inc.||Uterine manipulator and manipulator tip assembly|
|US5656036||12 Sep 1994||12 Aug 1997||Expandable Grafts Partnership||Apparatus for occluding vessels|
|US5669933||17 Jul 1996||23 Sep 1997||Nitinol Medical Technologies, Inc.||Removable embolus blood clot filter|
|US5766203||10 Oct 1996||16 Jun 1998||Intelliwire, Inc.||Sheath with expandable distal extremity and balloon catheters and stents for use therewith and method|
|US5836968||16 Jul 1997||17 Nov 1998||Nitinol Medical Technologies, Inc.||Removable embolus blood clot filter|
|US5919202||1 May 1997||6 Jul 1999||Yoon; Inbae||Surgical instrument with jaws and movable internal needle and method for use thereof|
|US5935137||18 Jul 1997||10 Aug 1999||Gynecare, Inc.||Tubular fallopian sterilization device|
|US6090063||21 Oct 1996||18 Jul 2000||C. R. Bard, Inc.||Device, system and method for implantation of filaments and particles in the body|
|US6096052||8 Jul 1998||1 Aug 2000||Ovion, Inc.||Occluding device and method of use|
|US6145505||28 May 1999||14 Nov 2000||Conceptus, Inc.||Electrically affixed transcervical fallopian tube occlusion devices|
|US6176240||7 Jun 1995||23 Jan 2001||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and their delivery|
|US6187027||13 Jan 2000||13 Feb 2001||Target Therapeutics, Inc.||Vaso-occlusive devices with heat secured polymer fiber|
|US6270495||22 Feb 1996||7 Aug 2001||Radiotherapeutics Corporation||Method and device for enhancing vessel occlusion|
|US6270515 *||26 Feb 1997||7 Aug 2001||Scimed Life Systems, Inc.||Device for closing a septal defect|
|US6312446 *||12 Sep 2000||6 Nov 2001||Scimed Life Systems, Inc.||Apparatus and method for closing a septal defect|
|US6378524||22 Feb 2000||30 Apr 2002||Jesse M. Jones||Method of sterilizing females|
|US6432116 *||21 Dec 1999||13 Aug 2002||Ovion, Inc.||Occluding device and method of use|
|US6517559||3 May 2000||11 Feb 2003||O'connell Paul T.||Blood filter and method for treating vascular disease|
|US6526979||12 Jun 2000||4 Mar 2003||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and methods|
|US6565557||9 Feb 2000||20 May 2003||Board Of Regents, The University Of Texas System||Apparatus and methods for fallopian tube occlusion|
|US6634361||1 Jun 1999||21 Oct 2003||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and methods|
|US6638293 *||31 Jan 1997||28 Oct 2003||Transvascular, Inc.||Methods and apparatus for blocking flow through blood vessels|
|US6679266||28 Mar 2002||20 Jan 2004||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and their delivery|
|US6684884||23 Jul 2001||3 Feb 2004||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and methods|
|US6705323||8 Jun 1998||16 Mar 2004||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and methods|
|US6706054||22 Dec 2000||16 Mar 2004||Ev3 Inc.||Body vessel filter|
|US6709667||22 Aug 2000||23 Mar 2004||Conceptus, Inc.||Deployment actuation system for intrafallopian contraception|
|US6716238||10 May 2001||6 Apr 2004||Scimed Life Systems, Inc.||Stent with detachable tethers and method of using same|
|US6763833||22 Aug 2000||20 Jul 2004||Conceptus, Inc.||Insertion/deployment catheter system for intrafallopian contraception|
|US6871650||12 Jun 2000||29 Mar 2005||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and their delivery|
|US6966892||7 Nov 2002||22 Nov 2005||Micrus Corporation||Apparatus for deployment of micro-coil using a catheter|
|US20020013589||18 Dec 1996||31 Jan 2002||Ovion, Inc.||Contraceptive system and method of use|
|US20020020417||23 Jul 2001||21 Feb 2002||Nikolchev Julian N.||Contraceptive transcervical fallopian tube occlusion devices and methods|
|US20020029051 *||21 Dec 1999||7 Mar 2002||Edward J. Lynch||Occluding device and method of use|
|US20030066533||5 Oct 2001||10 Apr 2003||Loy Randall A.||Removable fallopian tube plug and associated methods|
|US20040073242 *||5 Jun 2003||15 Apr 2004||Nmt Medical, Inc.||Patent foramen ovale (PFO) closure device with radial and circumferential support|
|US20040079377||20 Jun 2003||29 Apr 2004||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and methods|
|US20040127918||13 Aug 2003||1 Jul 2004||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and methods|
|US20040159324||12 Feb 2004||19 Aug 2004||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and their delivery|
|US20040163650||23 Feb 2004||26 Aug 2004||Conceptus, Inc.||Deployment actuation system for intrafallopian contraception|
|US20040163651||23 Feb 2004||26 Aug 2004||Conceptus, Inc.||Transcervical fallopian tube occlusion devices and their delivery|
|US20040206358||14 May 2004||21 Oct 2004||Conceptus, Inc., A California Corporation||Contraceptive transcervical fallopian tube occlusion devices and their delivery|
|US20040211429||14 May 2004||28 Oct 2004||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and their delivery|
|US20050085844||24 Dec 2003||21 Apr 2005||Ovion, Inc.||Contraceptive device and delivery system|
|US20050107867||10 Jan 2004||19 May 2005||Taheri Syde A.||Temporary absorbable venous occlusive stent and superficial vein treatment method|
|AU707047B2||Title not available|
|AU739429B2||Title not available|
|DE3038928A1||15 Oct 1980||29 Apr 1982||Bleier Waldemar||Expansion pessary for uterine tubes - with inner rigid core and outer soft elastic sleeve|
|EP0105669A1||21 Sep 1983||18 Apr 1984||Beta Phase Inc.||Method of contraception and apparatus for carrying out such method|
|EP1199049A1||19 Oct 2000||24 Apr 2002||Itzhak Dr. Shoher||Metallic composite surface composition for an implant structure|
|WO1990009158A1||23 Jan 1990||23 Aug 1990||Radelkis Elektrokémiai Mu^'szergyártó Ipari Szövetkezet||Intrauterine contraceptive device|
|WO1993006884A1||1 Oct 1992||15 Apr 1993||Target Therapeutics, Inc.||Vaso-occlusion coil with attached fibrous element(s)|
|WO1994024944A1||23 Apr 1993||10 Nov 1994||Bohdan Babinec||Method, device and apparatus for reversible contraceptive sterilization|
|WO1994026175A1||6 May 1994||24 Nov 1994||Vitaphore Corporation||Embolization device|
|WO1996040024A1||21 May 1996||19 Dec 1996||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices having mechanical fallopian tube attachment|
|WO1997027893A1||31 Jan 1997||7 Aug 1997||Transvascular, Inc.||Methods and apparatus for blocking flow through blood vessels|
|WO1998026737A1||16 Dec 1997||25 Jun 1998||Ovion, Inc.||Contraceptive system and method of use|
|WO1999015116A1||23 Sep 1998||1 Apr 1999||Conceptus, Inc.||Contraceptive transcervical fallopian tube occlusion devices and methods|
|WO2001013833A1||22 Aug 2000||1 Mar 2001||Conceptus, Inc.||Deployment actuation system for intrafallopian contraception|
|1||"Mammal erythrocyte sizes," Animal Genome Size Database, last modified by T. Ryan Gregory on Feb. 3, 2004, accessed at http://genomesize.com/cellsize/mammals.htm on May 26, 2011, 18 pages.|
|2||"sperm." Encyclopaedia Britannica. Encyclopaedia Britannica Online. Encyclopaedia Britannica, 2011, accessed at http://www.britannica.com/EBchecked/topic/559354/sperm on May 26, 2011.|
|3||A. Thurmond, MD, "Transcervical fallopian tube catheterization," Seminars in Interventional Radiology, vol. 9 (No. 2), pp. 80-86, (Jun. 1992).|
|4||Conceptus' Amended Answer to Ovion's Complaint, Affirmative Defenses and Counterclaims, Sep. 26, 2002.|
|5||Conceptus' Motion for Summary Judgment of Invalidity of the Asserted '116 patent Claims in View of Conceptus, Inc.'s '979 Patent, Oct. 6, 2003.|
|6||Conceptus' Second Amended Answer, Affirmative Defenses And Counterclaims For: (1) Declaratory Judgment Of Non-Infringement; (2) Declaratory Judgment Of Unenforceability; (3) Declaratory Judgment Of Invalidity; (4) Correction Of Inventorship of '052 Patent Under 35 USC §256; (5) Correction of Inventorship Of '116 Patent Under 35 USC §256; (6) Fraud And Deceit; (7) Trade Libel; (8) Slander Per Se; (9) Libel; (10) Unfair Competition; And, (11) Slander Of Title, Jul. 2, 2003.|
|7||Conceptus, Inc.'s Preliminary Invalidity Contentions, Apr. 30, 2003.|
|8||Curry, M.R., et al., "Surface Area and Volume Measurements for Ram and Human Spermatozoa," Biology of Reproduction, vol. 55, 1996, pp. 1325-1332.|
|9||Declaration of Dr. Gabor Thomas Kovacs (Australian Patent Application No. 769576) (Nov. 18, 2004).|
|10||Declaration of Dr. John F. Kerin (Australian Patent Application No. 769576) (Nov. 19, 2004).|
|11||Declaration of Julian Nikolchev (Australian Patent Application No. 769576) (Nov. 5, 2004).|
|12||Declaration of Kathryn Tunsdall (Australian Patent Application No. 769576) (Oct. 19, 2004).|
|13||Declaration of Leland G. Hansen In Support Of Ovion's Motion To Change Time, with Exhibits 1-8, Oct. 10, 2003.|
|14||Declaration of Steven Bachich in Support of Conceptus' Motion for Summary Judgment of Invalidity in View of Conceptus, Incs;s '979 Patent (Oct. 5, 2003).|
|15||Defendants' Request, Pursuant to Civil Local Rule 7-10(b), For Leave to File a Motion to Dismiss Before the Initial Case Management Conference (Jul. 22, 2002).|
|16||Docket for Civil Action No. C 02 1968 MHP (U.S. District Court for the Northern District of California).|
|17||Docket for Civil Action No. C 02 3884 MHP (U.S. District Court for the Northern District of California).|
|18||First Amended complain For (1) Declaratory Judgment of Patent Non-Infringement, Invalidity and Unenforceability; (2) False Advertising Under 15 USC §1125(A); (3) Trade Libel; (4) Unfair Competition Under Common Law and Cal. B&P §17200 Et Seq.; (5) Unjust Enrichment; and (6) Constructive Trust Demand for Jury Trial, Jun. 13, 2002.|
|19||First Amended Complaint For Willful Patent Infringement, Fraud And Misrepresentation, Misappropriation, Unjust Enrichment, Unfair Business Practices, Trade Libel, Slander Of Title, Monopolization, Attempt To Monopolize And Sham Litigation, Aug. 25, 2003.|
|20||International Search Report for PCT/US2005/003185, mailed May 2, 2005.|
|21||International Search Report for PCT/US2005/003310, mailed May 2, 2005.|
|22||Joint Claim Construction and Prehearing Statement Pursuant To Patent Local Rule 4-3, Aug. 6, 2003.|
|23||Letter from E. Brann to Judge Patel with signed declaration of A. Khera, Aug. 13, 2003.|
|24||Letter from J. Benassi to Judge Patel, Aug. 28, 2003.|
|25||Letter from J. Benassi to Judge with declarations of E. Brann and A. Khera, Aug. 8, 2003.|
|26||Letter from L. Hansen to Judge Patel, Aug. 15, 2003.|
|27||Letter from L. Hansen to Judge Patel, Aug. 5, 2003.|
|28||Letter from L. Hansen to Judge Patel, Aug. 7, 2003.|
|29||Letter from L. Hansen to Judge Patel, enclosing for submission on behalf of Ovion its First Amended Complaint, Aug. 25, 2003.|
|30||Letter from L. Hansen to Judge Patel, Jul. 28, 2003.|
|31||Notice of Opposition (Australian Patent Application No. 769576) (Apr. 27, 2004).|
|32||Ovion's Corrected Disclosure of Asserted Claims and Preliminary Infringement Contentions, Nov. 19, 2002.|
|33||Ovion's Corrected Supplemental Statement Regarding Dates of Invention, Nov. 19, 2002.|
|34||Ovion's Motion to Change Time for Conceptus' Inappropriate Summary Judgement Motions, Oct. 10, 2003.|
|35||Ovion's Motion To Change Time for Conceptus' Inappropriate Summary Judgment Motions, Oct. 10, 2003.|
|36||Ovion's Reply To Amended Counterclaims Of Conceptus, Oct. 25, 2002.|
|37||Ovion's Request, Pursuant to Civil Local Rule 7-10(b), For Leave To File A Motion To Dismiss Before The Initial Case Management Conference.|
|38||Ovion's Response to Conceptus' Interrogatories Nos. 2-4, 6-10, and 12-13, Nov. 1, 2002.|
|39||Ovion's Second Supplemental Statement Regarding Dates of Invention, Dec. 20, 2002.|
|40||PCT International Preliminary Report on Patentability for PCT/US2005/003185 mailed Aug. 17, 2006.|
|41||PCT International Preliminary Report on Patentability for PCT/US2005/003310 mailed Aug. 17, 2006.|
|42||Plaintiff Conceptus Inc.'s Corrected Supplemental Response to Defendant Ovion, Inc.'s Interrogatory No. 1, Jan. 6, 2003.|
|43||Plaintiff Conceptus Inc.'s Initial Disclosure Pursuant to Fed.R.Civ.P. 26(a)(1), Nov. 1, 2002.|
|44||Plaintiff Conceptus, Inc.'s Corrected Supplemental Written Statement Concerning Dates of Invention, Jan. 6, 2003.|
|45||Plaintiff Conceptus, Inc.'s Response to Defendant Ovion, Inc.' First Set of Interrogatories Nos. 1-6, Nov. 1, 2002.|
|46||Plaintiff Conceptus, Inc.'s Supplemental Response to Defendant Ovion, Inc.'s Interrogatory No. 1, Dec. 20, 2002.|
|47||Plaintiff Conceptus, Inc.'s Supplemental Written Statement Concerning Dates of Invention, Dec. 20, 2002.|
|48||Second Declaration of Dr. John F. Kerin (Australian Patent Application No. 769576) (Nov. 19, 2004).|
|49||Statement of Grounds and Particulars (Australian Patent Application No. 769576) (Aug. 5, 2004).|
|50||Stipulation And Order Of Dismissal, Nov. 13, 2003.|
|51||T. Schmitz-Rode, MD, et al., "Experimental nonsurgical female sterilization: transcervical implantation of microspindles in fallopian tubes," Journal of Vascular and Interventional Radiology, vol. 5 (No. 6), pp. 905-910, (Nov.-Dec. 1994).|
|52||T. Schmitz-Rode, MD, et al., "Self-expandable spindle for transcatheter vascular occlusion: in vivo experiments," Radiology, vol. 188 (No. 1), pp. 95-100, (Jul. 1993).|
|53||Vander, Arthur J., et al., "Human Physiology-The Mechanisms of Body Function" 2nd edition, McGraw-Hill Book Company, 1975, p. 299.|
|54||Vander, Arthur J., et al., "Human Physiology—The Mechanisms of Body Function" 2nd edition, McGraw-Hill Book Company, 1975, p. 299.|
|55||Written Opinion of the International Searching Authority for PCT/US2003/41275, mailed Apr. 25, 2005.|
|56||Written Opinion of the International Searching Authority for PCT/US2005/003185, mailed May 2, 2005.|
|57||Written Opinion of the International Searching Authority for PCT/US2005/003310, mailed May 2, 2005.|
|International Classification||A61F6/22, A61B17/12, A61F6/20, A61F6/16, A61B17/00|
|Cooperative Classification||A61F6/225, A61B17/0057, A61F6/20, A61F6/22, A61B17/12177, A61B17/12172, A61B17/12181, A61B17/12022, A61B17/12163, A61B17/12136, A61B17/1215, A61B2017/12095, A61B2017/12054|
|18 Oct 2005||AS||Assignment|
Owner name: OVION, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CALLISTER, JEFFREY P.;TREMULIS, WILLIAM S.;REEL/FRAME:017111/0523
Effective date: 20051012
Owner name: AMS RESEARCH CORPORATION, MINNESOTA
Free format text: MERGER;ASSIGNOR:OVION, INC.;REEL/FRAME:017112/0186
Effective date: 20051012
|10 Dec 2009||AS||Assignment|
Owner name: CONCEPTUS, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:AMS RESEARCH CORPORATION;REEL/FRAME:023627/0861
Effective date: 20090930
Owner name: CONCEPTUS, INC.,CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:AMS RESEARCH CORPORATION;REEL/FRAME:023627/0861
Effective date: 20090930
|26 Aug 2011||AS||Assignment|
Owner name: WELLS FARGO BANK, NATIONAL ASSOCIATION, CALIFORNIA
Free format text: SECURITY AGREEMENT;ASSIGNOR:CONCEPTUS, INC.;REEL/FRAME:026817/0493
Effective date: 20110825
|19 Apr 2013||AS||Assignment|
Owner name: CONCEPTUS, INC., CALIFORNIA
Free format text: RELEASE BY SECURED PARTY;ASSIGNOR:WELLS FARGO BANK, NATIONAL ASSOCIATION;REEL/FRAME:030249/0431
Effective date: 20130419
|16 Jan 2014||AS||Assignment|
Owner name: BAYER ESSURE INC., CALIFORNIA
Free format text: CHANGE OF NAME;ASSIGNOR:CONCEPTUS, INC.;REEL/FRAME:032075/0466
Effective date: 20131025
|5 Aug 2015||AS||Assignment|
Owner name: BAYER HEALTHCARE LLC, NEW JERSEY
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Effective date: 20150711